Abstract 3371
Background
The prognosis of osteosarcoma at its metastatic stage remains unchanged over the last several decades. Although 60∼80% first pulmonary recurrences were reportedly to be resectable, it’s surprising that the vast majority of trials to date were designed for metastatic osteosarcoma that were considered inoperable. Apatinib, a VEGFR2 inhibitor, is marked by its superior overall response rate (ORR) of ∼55% compared with other anti-angiogenic agents. Therefore, we aim to assess the efficacy and safety of incorporating apatinib with second-line chemotherapy preoperatively for resectable pulmonary metastatic osteosarcoma, with the intent to shrink the lesions for easier resection and eradicate the micro-metastatic residue using the combination therapy.
Trial design
This study is a multicenter, open-label, randomized phase II trial (ClinicalTrials ID: NCT03742193) in which ∼180 participants were to be randomized to an active control arm and an intervention arm in 1:1 ratio. Patients in the intervention arm will receive 250mg apatinib twice daily combined with gemcitabine-docetaxel (GD) regimen before and after the pulmonary metastasectomy, while the control arm will receive gemcitabine-docetaxel (GD) regimen only. Osteosarcoma patients with pulmonary recurrence only, which are potentially resectable at baseline will be recruited in the trial. The primary endpoint is progression-free survival (PFS) and the pre-specified target is an at least 30% decrease of hazard rate of progression in the experimental arm compared with the control arm. Error rate level of the trial was set at an one-sided α value of 0.1 and a power (1-β value) of 0.8, with mid-term assessment for both early efficacy and futility. Secondary objectives are to analyze the effect of the new regimen on overall survival, total resectability, objective response rate, clinical benefit rate, tolerability, as well as the potential predictive biomarker(s).
Clinical trial identification
NCT03742193; release date: March 2018.
Editorial acknowledgement
Legal entity responsible for the study
An IIT trial by Ruijin Hospital, Orthopaedic oncology group.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
5135 - Dose adjustment of chemotherapy in aggressive lymphoma using automated and standardized analysis and evaluation of DNA double strand breaks
Presenter: Julia Schröder
Session: Poster Display session 1
Resources:
Abstract
4883 - A New Population Model Validated Pharmacokinetic Similarity of HLX01 and Rituximab in B-Cell Lymphoma
Presenter: Yuankai Shi
Session: Poster Display session 1
Resources:
Abstract
4908 - Efficacy of salvage therapy in the treatment of Helicobacter pylori-positive gastric low-grade mucosa-associated lymphoid tissue lymphoma
Presenter: Sung-Nam Lim
Session: Poster Display session 1
Resources:
Abstract
2360 - Mutational analysis of extranodal marginal zone lymphoma using next generation sequencing
Presenter: Seok Jae Huh
Session: Poster Display session 1
Resources:
Abstract
2430 - Clinical features, treatment and outcomes of colon and rectum mucosa-associated lymphoid tissue (MALT) lymphoma: Literature reviews published in English between 1993 and 2017
Presenter: Jeong Yeon Kim
Session: Poster Display session 1
Resources:
Abstract
4654 - Splenic marginal zone lymphoma: clinical characteristics and prognostic factors in a series of 52 patients
Presenter: Guldane Cengiz Seval
Session: Poster Display session 1
Resources:
Abstract
1732 - Safety and efficacy of Bendamustine and Rituximab (BR) regimen in Indian Chronic Lymphocytic Leukemia patients
Presenter: Ajay Gogia
Session: Poster Display session 1
Resources:
Abstract
5784 - N-terminal B-type natriuretic peptide (NT-proBNP) as an independed prognostic marker for patients with newly diagnosed multiple myeloma complicated by dialysis-dependent renal failure
Presenter: Sergey Semochkin
Session: Poster Display session 1
Resources:
Abstract
836 - The first-line effect of Bortezomib-based Therapy on Clinical Outcomes for Taiwanese Patients with multiple myeloma
Presenter: Ching-Liang Ho
Session: Poster Display session 1
Resources:
Abstract
2085 - Impact of Donor Lymphocyte Infusion in Relapsing Myeloid Neoplasms Post Allogeneic Hematopoietic Stem Cell Transplantation
Presenter: Hanafy Hafez
Session: Poster Display session 1
Resources:
Abstract